Contents:

CHAPTER 1 EXECUTIVE SUMMARY Scope of the analysis Datamonitor insight into the NHL market Contributing experts Related reports Upcoming related reports CHAPTER 2 INTRODUCTION AND SCOPE Disease definition and epidemiology Current treatment practice for DLBCL and FL Treatment trends for DLBCL and FL Improving treatment outcomes Assumptions and caveats CHAPTER 3 EPIDEMIOLOGY AND PATIENT SEGMENTATION Introduction Disease classification NHL is classified under the WHO classification system NHL can follow an aggressive or indolent disease course Diffuse large B-cell lymphoma (DLBCL) is an aggressive lymphoma Follicular lymphoma (FL) is an indolent lymphoma FL is graded according to the proportion of large cells in the lymphoma Immunophenotype differs between NHL subtypes Diagnosis, staging and prognosis in non-Hodgkin’s lymphomas (NHL) Diagnosis of NHL Ann Arbor staging system The Ann Arbor classification is used for staging NHL but is of limited prognostic use Determining prognosis for NHL International Prognostic Index (IPI) for aggressive NHL International Prognostic Index for FL (FLIPI) Molecular profiling in NHL Etiology Immunodeficiency and immunosuppression as risk factors for non-Hodgkin's lymphomas (NHL) Acquired immunodeficiency syndrome (AIDS) Congenital immunodeficiency Immunosuppressive drugs Autoimmune disorders Infections as risk factors for NHL Human T-cell lymphotrophic virus (HTLV-1) Epstein-Barr virus (EBV) Helicobacter pylori Hepatitis C Occupational, environmental and lifestyle risk factors Pesticides Lifestyle factors Epidemiology NHL cases will total over 125,000 in the seven major markets in 2009 Increase in NHL incidence linked to an aging population Forecast incidence of diffuse large B-cell lymphoma (DLBCL) in the seven major markets DLBCL is the most common subtype of NHL Forecast incidence of follicular lymphoma (FL) in the seven major markets. FL is the second most common subtype of NHL CHAPTER 4 TREATMENT TREES: DIFFUSE LARGE B-CELL LYMPHOMA Introduction Diffuse large B-cell lymphoma (DLBCL) treatment trees US Japan France Germany Italy Spain UK CHAPTER 5 TREATMENT TRENDS: DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL) Overview Treatment rates Induction therapy R-CHOP is a standard of care for induction therapy in DLBCL Maintenance therapy Second-line therapy Candidates for stem cell transplantation (SCT) Non-candidates for stem cell transplantation (SCT) Stem cell transplantation (SCT) in diffuse large B-cell lymphoma (DLBCL) Third-line therapy Relapse following second-line chemotherapy and stem cell transplantation (SCT) Relapse following second-line chemotherapy alone CHAPTER 6 IMPROVING TREATMENT OUTCOMES: DIFFUSE LARGE B-CELL LYMPHOMA Treatment outcomes Unmet needs Determining the best salvage therapy for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) Inclusion of molecular profiling in current treatment strategies Factors influencing prescribing decision in diffuse large B-cell lymphoma (DLBCL) Efficacy is the most important prescribing influence for DLBCL Incorporation of pipeline drugs into treatment Pixantrone (Cell Therapeutics/Roche) The uptake of pixantrone will depend on its toxicity profile Afinitor (everolimus; Novartis) Afinitor may struggle to secure approval as a maintenance therapy for DLBCL Arzerra (ofatumumab; Genmab/GlaxoSmithKline) Genmab shifts its attention to DLBCL Avastin (bevacizumab; Genentech/Roche/Chugai) Whether the addition of Avastin to R-CHOP improves outcomes in DLBCL is still unclear Revlimid (lenalidomide; Celgene) Revlimid shows good single-agent activity in relapsed/refractory DLBCL patients Enzastaurin (Eli Lilly) Enzastaurin shows marginal single-agent activity in relapsed/refractory DLBCL CHAPTER 7 TREATMENT TREES: FOLLICULAR LYMPHOMA Introduction Follicular lymphoma (FL) treatment trees US Japan France Germany Italy Spain UK CHAPTER 8 TREATMENT TRENDS: FOLLICULAR LYMPHOMA (FL) Overview Treatment rates Induction therapy R-CHOP and R-CVP are the most popular induction regimens The advantage of multiple courses of Rituxan remains unclear Considerable uptake of Rituxan monotherapy in the induction setting Maintenance following induction therapy Rituxan maintenance after first-line and second-line therapy improves PFS and overall survival in FL Second-line therapy Stem cell transplantation (SCT) in follicular lymphoma (FL) The use of reduced-intensity conditioning (RIT) may make allogeneic stem cell transplantation (alloSCT) feasible in more patients Treanda in the treatment of follicular lymphoma Radioimmunotherapies in the treatment of follicular lymphoma Maintenance following second-line therapy Third-line therapy CHAPTER 9 IMPROVING TREATMENT OUTCOMES: FOLLICULAR LYMPHOMA (FL) Treatment outcomes Unmet needs Novel therapies are required to improve treatment outcomes Factors influencing prescribing decisions in follicular lymphoma (FL) Efficacy is the most important prescribing decisions for FL Incorporation of pipeline drugs into treatment Velcade (Millennium/Johnson & Johnson) The combination of Velcade with Rituxan is active in the first-line treatment of indolent non-Hodgkin's lymphomas (NHL) It is unclear how Millennium will position Velcade in the treatment of FL BiovaxID (Biovest/Accentia) Phase III trial data show improvement in PFS, but are not clinically relevant Galiximab (Biogen Idec) Pixantrone (Cell Therapeutics/Roche) Two Phase III trials in indolent non-Hodgkin's lymphomas (NHL) have been closed BIBLIOGRAPHY Journal papers Websites Datamonitor reports APPENDIX A Physician research methodology Physician sample breakdown US Japan France Germany Italy Spain UK Contributing experts APPENDIX B The survey questionnaire Introduction Section 1 - Diffuse large B-cell lymphoma: Patient Segmentation Section 2 - Diffuse large B-cell lymphoma: Treatment Section 3 - Diffuse large B-cell lymphoma: Product Profiles and Pipeline Products Section 4 - Follicular lymphoma: Patient Segmentation Section 5 - Follicular lymphoma: Treatment Section 6 - Follicular lymphoma: Product Profiles and Pipeline Products About Datamonitor About Datamonitor Healthcare About the Oncology analysis team Disclaimer